0 Ratings
ID

44226

Description

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the prior medication form. It has to be filled in for screening.

Keywords

Versions (3)
  1. 4/15/19 4/15/19 -
  2. 4/15/19 4/15/19 -
  3. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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    Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

    English

    Prior Medication

    1 forms  
    1. StudyEvent: ODM
      1. Prior Medication
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject No.
    Description

    Subject No.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Panel ID
    Description

    Panel ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C3846158 (Other Coding)
    LOINC
    LA4728-7
    Visit Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Prior Medication
    Description

    Prior Medication

    Alias
    UMLS CUI-1
    C2826257 (Prior Medication Usage)
    Has the subject taken any prescribed medication within 14 days prior to first dosing day or any OTC medicine within 7 days before the first study day?
    Description

    If 'YES', please record the medications below.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3166216 (Prescribed medications)
    LOINC
    LP124834-5
    UMLS CUI [2]
    C0013231 (Drugs, Non-Prescription)
    DRUG NAME
    Description

    (Trade Name Preferred)

    Data type

    text

    Alias
    UMLS CUI [1]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Single Dose/Unit (e.g.500 mg)
    Description

    Single Dose/Unit

    Data type

    text

    Alias
    UMLS CUI [1]
    C1960417 (Single dose characteristic)
    SNOMED
    426146003
    Frequency of this Dose (e.g.BID, PR)
    Description

    Frequency of this Dose

    Data type

    text

    Alias
    UMLS CUI [1]
    C3476109 (Medication frequency)
    LOINC
    LP149758-7
    Route
    Description

    Route

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    Indication
    Description

    Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3146298 (Indication)
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Duration of therapy (e.g.6 years)
    Description

    Duration of therapy

    Data type

    text

    Alias
    UMLS CUI [1]
    C0444921 (Duration of treatment)
    SNOMED
    261773006
    End Date
    Description

    Day/Month/Year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Continuing at end of study?
    Description

    Continuing at end of study

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1553904 (continuing therapy)
    UMLS CUI [1,2]
    C2983670 (Study End Date)
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    Similar models

    Prior Medication

    1 forms
    1. StudyEvent: ODM
      1. Prior Medication
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject No.
    Item
    Subject No.
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID
    text
    C3846158 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Prior Medication
    C2826257 (UMLS CUI-1)
    Prescribed or OTC medication
    Item
    Has the subject taken any prescribed medication within 14 days prior to first dosing day or any OTC medicine within 7 days before the first study day?
    boolean
    C3166216 (UMLS CUI [1])
    C0013231 (UMLS CUI [2])
    DRUG NAME
    Item
    DRUG NAME
    text
    C2360065 (UMLS CUI [1])
    Single Dose/Unit
    Item
    Single Dose/Unit (e.g.500 mg)
    text
    C1960417 (UMLS CUI [1])
    Frequency of this Dose
    Item
    Frequency of this Dose (e.g.BID, PR)
    text
    C3476109 (UMLS CUI [1])
    Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Indication
    Item
    Indication
    text
    C3146298 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Duration of therapy
    Item
    Duration of therapy (e.g.6 years)
    text
    C0444921 (UMLS CUI [1])
    End Date
    Item
    End Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Continuing at end of study
    Item
    Continuing at end of study?
    boolean
    C1553904 (UMLS CUI [1,1])
    C2983670 (UMLS CUI [1,2])
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